METOCLOPRAMIDE TABLETS BP 10MG

Transcript

Metoclopramide 10mg tablets
Read all of this leaflet carefully before you start
taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor
or pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.

Index

1 What Metoclopramide tablets are and
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Metoclopramide tablets are and what they

are used for
Metoclopramide tablets are an antiemetic. It works on a part of
your brain that prevents you from feeling sick (nausea) or being sick
(vomiting).
Adults
Metoclopramide tablets are used in adults:
• to prevent delayed nausea and vomiting that may occur after
chemotherapy
• to prevent nausea and vomiting caused by radiotherapy
• to treat nausea and vomiting including nausea and vomiting which
may occur with a migraine.
Metoclopramide can be taken with oral painkillers in case of
migraine to help painkillers work more effectively.
Children and adolescents
Metoclopramide tablets are indicated in children (aged 15-18 years)
if other treatment does not work or cannot be used to prevent
delayed nausea and vomiting that may occur after chemotherapy

2 Before you take

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Metoclopramide tablets if you:
• have a history of abnormal heart beats (QT interval prolongation)
or any other heart problems
• have problems with the levels of salts in your blood, such as
potassium, sodium and magnesium.
• are using other medicines known to affect the way your heart
beats
• have any neurological (brain) problems
• have liver or kidney problems. The dose may be reduced (see
section 3).

Blood tests

Your doctor may perform blood tests to check your blood pigment
levels. In cases of abnormal levels (methaemoglobinemia), the
treatment should be immediately and permanently stopped.
Do not exceed 3-month treatment because of the risk of involuntary
muscle spasms.

Children and adolescents

Uncontrollable movements (extrapyramidal disorders) may
occur in children and young adults. This medicine must not be
used in children below 1 years of age because of the increased
risk of the uncontrollable movements (see above “Do not take
Metoclopramide tablets if”).

Other medicines and Metoclopramide tablets

Tell your doctor, pharmacist or nurse if you are taking, have recently
taken or might take any other medicines. This is because some
medicines can affect the way Metoclopramide tablets works or
Metoclopramide tablets can affect how other medicines work.
These medicines include the following:
• levodopa or other medicines used to treat Parkinson’s disease
(see above “Do not take Metoclopramide tablets if”)
• anticholinergics (medicines used to relieve stomach cramps or
spasms)
• morphine derivatives (medicines used to treat severe pain)
• sedative medicines
• any medicines used to treat mental health problems
• digoxin (medicine used to treat heart failure)
• ciclosporin (medicine used to treat certain problems with the
immune system)
• mivacurium and suxamethonium (medicines used to relax
muscles)
• fluoxetine and paroxetine (medicine used to treat depression)

Metoclopramide tablets with alcohol

Do not take Metoclopramide tablets if you:

• are allergic to metoclopramide or any of the other ingredients of
this medicine (listed in section 6).
• have bleeding, obstruction or a tear in your stomach or gut.
• you have or may have a rare tumour of the adrenal gland, which
sits near the kidney (pheochromocytoma).
• have ever had involuntary muscle spasms (tardive dyskinesia),
when you have been treated with a medicine.
• have epilepsy
• have Parkinson’s disease
• are taking levodopa (a medicine for Parkinson’s disease) or
dopaminergic agonists (see below “Other medicines and
Metoclopramide tablets”)
• have ever had an abnormal blood pigment levels
(methaemoglobinemia) or NADH cytochromeb5 Deficiency
Do not give Metoclopramide tablets to a child less than 1 years of
age (see below “Children and adolescents”).
Continued top of next column

Alcohol should not be consumed during treatment with
metoclopramide because it increases the sedative effect of
Metoclopramide tablets.

Pregnancy, breast-feeding

If you are pregnant, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before being
given this medicine. If necessary, Metoclopramide tablets may be
taken during pregnancy. Your doctor will decide whether or not you
should be given this medicine.
Metoclopramide tablets are not recommended if you are breastfeeding because metoclopramide passes into breast milk and may
affect your baby.

Driving and using machines

You may feel drowsy, dizzy or have uncontrollable twitching, jerking
or writhing movements and unusual muscle tone causing distortion
of the body after taking Metoclopramide tablets. This may affect
your vision and also interfere with your ability to drive and use
machines.
Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Metoclopramide 10mg Tablets PIL - UK

colours/plates:
1. Black

item no: AAAG5379 50774320

dimensions: 148 x 210 (Reel Fed)

print proof no: 5

pharmacode: 3871

origination date: 06.02.14

min pt size: 7pts

3.
4.
5.
6.

originated by: S.Anson
approved for print/date

2.

revision date: 21.07.14

Technical Approval

revised by: S.Anson

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact
your doctor before taking this medicine, as it contains a type of sugar
called lactose.

3 How to take
Adults
The recommended single dose is 10mg, repeated up to three times daily.
The maximum recommended dose per day is 30mg or 0.5mg/kg body
weight.
The maximum recommended treatment duration is 5 days.
Children and Adolescents
To prevent delayed nausea and vomiting that may occur after
chemotherapy (children aged 15-18 years)
The recommended dose is 0.1 to 0.15mg/kg body weight, repeated up to
3 times daily, taken by mouth (oral route).
The maximum dose in 24 hours is 0.5mg/kg body weight.
You should not take this medicine for more than 5 days to prevent
delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramide tablets is not suitable for use in children weighing less
than 61 kg.
Other pharmaceutical forms/strengths may be more appropriate for
administration.

Method of administration

You must wait at least 6 hours between each metoclopramide dose, even
in case of vomiting and rejection of the dose, in order to avoid overdose.

Older people

The dose may need to be reduced depending on kidney problems, liver
problems and overall health.

Adults with kidney problems

Talk to your doctor if you have kidney problems. The dose should be
reduced if you have moderate or severe kidney problems.

Adults with liver problems

Talk to your doctor if you have liver problems. The dose should be reduced
if you have severe liver problems.

Children and adolescents

Metoclopramide must not be used in children aged less than 1 years
(see section 2).

If you take more Metoclopramide tablets than you should

Contact your doctor or pharmacist straight away. You may experience
uncontrollable movements (extrapyramidal disorders), feel drowsy, have
some troubles of consciousness, be confused, have hallucination and
heart problems. You doctor may prescribe you a treatment for these signs
if necessary.

If you forget to take Metoclopramide tablets

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your
doctor, nurse or pharmacist.

Very common (may affect more than 1 in 10 people)
• feeling drowsy
Common (may affect up to 1 in 10 people)
• depression
• uncontrollable movements such as tics, shaking, twisting movements
or muscle contracture (stiffness, rigidity)
• symptoms similar to Parkinson disease (rigidity, tremor)
• feel restless
• blood pressure decrease (particularly with intravenous route)
• diarrhoea
• feeling weak
Uncommon (may affect up to 1 in 100 people)
• raised levels of a hormone called prolactin in the blood which may
cause milk production in men, and women who are not breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly with intravenous route)
• allergy
Rare (may affect up to 1 in 1,000 people)
• confusional state
• convulsion (especially in patients with epilepsy)
Not known (frequency cannot be estimated from the available data)
• abnormal blood pigment levels which may change the colour of your
skin
• abnormal development of breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly
patients
• changes in heart beat, which may be shown on an ECG test
• cardiac arrest (particularly with injection route)
• shock (severe decrease of heart pressure) (particularly with injection
route)
• fainting (particularly with intravenous route)
• very high blood pressure
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any side effects not listed in this leaflet.

5 How to store
Keep out of the reach and sight of children.
Store below 25ºC in a dry place and protected from light.
Do not use Metoclopramide tablets after the expiry date stated on the
label/carton/bottle. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

What Metoclopramide tablets look like and
contents of the pack
Metoclopramide tablets are white uncoated tablets.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop the treatment and talk straight away to your doctor, pharmacist
or nurse if you experience one of the following signs while having
this medicine:
• uncontrollable movements (often involving head or neck). These may
occur in children or young adults and particularly when high doses are
used. These signs usually occur at the beginning of treatment and may
even occur after one single administration. These movements will stop
when when treated appropriately.
• high fever, high blood pressure, convulsions, sweating, production of
saliva. These may be signs of a condition called neuroleptic malignant
syndrome.
• itching or skin rashes, swelling of the face, lips or throat, difficulty in
breathing. These may be signs of an allergic reaction, which may be
severe.
Continued top of next column

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